| K-number | K260212 |
| Device name | EnSite X EP System |
| Applicant | ABBOTT MEDICAL |
| Product code | DQK |
| Device class | Class II |
| Decision date | Apr 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The EnSite™ X EP System is a catheter navigation and mapping system that displays the 3D position of electrophysiology catheters and visualizes cardiac electrical activity during EP procedures. It includes a Contact Force Software License module for force visualization and a Surface Electrode Kit, and is indicated as a diagnostic tool for patients undergoing electrophysiology studies.
The subject device (Version 6.0 with TactiFlex™ Duo Software Licenses) uses the same fundamental technology as the predicate devices (v5.0 and v4.0) for catheter positioning, orientation, cardiac mapping, and 3D model creation. The key update is compatibility with the TactiFlex™ Duo Ablation Catheter with Sensor Enabled™ technology.
Testing followed IEC 62304 (Medical Device Software lifecycle), IEC 60601-1-2:2020 (electromagnetic safety), ISO 14971:2019 (risk management), IEC 62366-1:2015+A1:2020 (usability engineering), and FDA guidance for software in medical devices. Verification and validation activities were conducted at unit, software, system, and device levels.
The subject and predicate devices share identical intended use and indications for use, operating via the same fundamental scientific principles for catheter positioning and cardiac mapping. All risks were mitigated to acceptable levels with no new safety or effectiveness concerns raised. The testing demonstrates objective equivalence to predicate devices K251234 and K252013.
View the full FDA submission: accessdata.fda.gov